The NIH is offering grants for Small Business Concerns to conduct analytical validation of candidate biomarkers for neurological diseases following FDA guidelines. The validation process aims to ensure the biomarker’s performance characteristics meet the required standards for its intended use. Closing date for applications is September 7, 2020.
Opportunity ID: 299662
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-549 |
| Funding Opportunity Title: | Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 22, 2017 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Sep 07, 2020 |
| Current Closing Date for Applications: | Sep 07, 2020 |
| Archive Date: | Oct 13, 2020 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed. see funding announcement for eligibility |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-549.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-E | Use for due dates on or before May 24, 2020 | PKG00237272 | Feb 14, 2018 | May 24, 2020 | View | |
| FORMS-F | Use for due dates on or after May 25, 2020 | PKG00260214 | Feb 14, 2018 | Sep 07, 2020 | View |
Package 1
Mandatory forms
299662 RR_SF424_2_0-2.0.pdf
299662 PHS398_CoverPageSupplement_4_0-4.0.pdf
299662 RR_OtherProjectInfo_1_4-1.4.pdf
299662 PerformanceSite_2_0-2.0.pdf
299662 RR_KeyPersonExpanded_2_0-2.0.pdf
299662 RR_Budget_1_4-1.4.pdf
299662 PHS398_ResearchPlan_4_0-4.0.pdf
299662 SBIR_STTR_Information_1_2-1.2.pdf
Optional forms
299662 RR_SubawardBudget30_1_4-1.4.pdf
299662 PHS_AssignmentRequestForm_2_0-2.0.pdf
Package 2
Mandatory forms
299662 RR_SF424_2_0-2.0.pdf
299662 PHS398_CoverPageSupplement_5_0-5.0.pdf
299662 RR_OtherProjectInfo_1_4-1.4.pdf
299662 PerformanceSite_2_0-2.0.pdf
299662 RR_KeyPersonExpanded_2_0-2.0.pdf
299662 RR_Budget_1_4-1.4.pdf
299662 PHS398_ResearchPlan_4_0-4.0.pdf
299662 SBIR_STTR_Information_1_3-1.3.pdf
299662 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
299662 RR_SubawardBudget30_1_4-1.4.pdf
299662 PHS_AssignmentRequestForm_3_0-3.0.pdf
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